SUPPLY CHAIN ARTICLES

  • Can America's Retreat On mRNA Be Europe's Opportunity?

    With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.

  • mRNA Vaccines: Key Considerations For Development & Manufacturing

    As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more. 

  • Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions

    Overall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem. 

  • “Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA

    It goes without saying we have some pretty ambitious therapeutic goals for linear mRNA and next-gen saRNA and circRNA. However, as my conversation with Koeris explored, we still have a lot of scientific and technical work/innovation ahead of us to make our RNA products “stronger” (in more ways than one).

  • Inside Alnylam's Playbook For High Volume siRNA Production

    As one of the first companies to establish a chemoenzymatic ligation platform, Alnylam's Maines and Nechev are in the perfect position to espouse wisdom on the practical aspects and remaining challenges of implementing enzymatic ligation at a large scale. Here in this installment, Maines and Nechev outline what they’ve learned thus far about the science of enzymatic ligation, while also paying credence to the unknowns and existing barriers that, as a frontrunner, Alnylam will inevitably (but willingly) be tasked with facing in the future.

  • Picasso, Pick-Up Lines, & Personalized Medicine: mRNA's Path Forward

    Overall, my presentation on what the mRNA industry can learn from the artist Picasso singled out a few specific areas from which I felt our industry could garner greater inspiration and operational prowess. But given how “collaborative” many of these sources of inspiration are, I’ve introduced each of my takeaways with a surprisingly relevant (albeit bad) art-themed pick-up line. After all, if there’s one sector that knows it takes more than one to “tango,” it’s the mRNA industry.

SUPPLY CHAIN VIDEOS

Large scale production of plasmid DNA requires an in-depth understanding and optimization of the entire downstream process. Explore a complete solution, from harvest to bulk filtration.

Can we actually achieve metric-ton siRNA production today using enzymatic ligation? While the ligation step is highly scalable, upstream "blockmer" synthesis remains the primary bottleneck. Advancing RNA Live panelists Claire McCleod and Jill Caswell discuss the shift from "scaling out" to "scaling up" and lessons learned in the process of achieving larger scale production. 

In this Advancing RNA Live clip, Sail Biomedicines’ Marc Wolfgang gives us a brief primer on the main differences and challenges in developing an IVT reaction for circular RNA, as opposed to linear mRNA.    

This Advancing RNA Live clip dives into the biggest challenges in mRNA purification and the critical debate on where to focus investment. Here, our three mRNA PD experts argue for a holistic process development strategy, challenging the traditional wisdom of optimizing the upstream process at any cost.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS